Viewing Study NCT06513013



Ignite Creation Date: 2024-10-26 @ 3:35 PM
Last Modification Date: 2024-10-26 @ 3:35 PM
Study NCT ID: NCT06513013
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-07-04

Brief Title: MgSO4 as Adjuvants to Bupivacaine vs Neostigmine in TAP Block in Cesarean Section
Sponsor: None
Organization: None

Study Overview

Official Title: Comparative Evaluation of Magnesium Sulphate Versus Neostigmine as an Adjuvant to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane TAP Block as Postoperative Analgesia in Cesarean Section
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The aim of this study is to compare the duration of analgesia obtained by addition of Neostigmine versus MgSO4 as adjuvants to bupivacaine in TAP block in patients undergoing Cesarean Section and to evaluate postoperative analgesic requirements side effects and level of patient satisfaction
Detailed Description: Caesarean section CS is one of the most operations in the world Effective postoperative analgesia after it is very important because it encourages breast feeding and facilitates early ambulation and recovery Postoperative analgesia is too important to prevent unwanted side effects such as venous thromboembolism respiratory complications and increased hospital stayPost Caesarean discomfort and pain is expected so the analgesic regimen should assure safe and efficient sedation Commonly opioids and NSAIDs are used for post caesarean pain relief While dose dependent respiratory depression is the most discomforting side effect other insignificant side effects such as gastrointestinal upset pruritus and urinary retention can be annoying during the first hours of puerperium The transversus abdominus plane TAP block has been used for postoperative pain relief in different abdominal surgeries as part of the multimodal anesthetic approachIt creates satisfactory somatic anesthesia with no visceral blockade Its widespread use in abdominal surgeries is due to its technical simplicity and trustworthy analgesia This block implies administering local anesthetic between the internal oblique muscle and transversus abdominis muscle which is marked by the lumbar Petit triangle The primary drawback of single-shot regional blocks is their short duration of action when administered with local anesthetic alone Several adjuvants including opioids alpha 2 agonistsNeostigmine N-methylD-aspartate NMDA receptor antagonists and other drugs have been utilized to extend the duration of blocks Opioids are by far the most often used adjuvants but they accompany a host of unpleasant side effects such as respiratory depression drowsiness nausea and vomiting In some studies using alpha 2 agonists such as Dexmedetomidine and Clonidine has been related to drowsiness and bradycardia

MgSO4 is an N-methyl-D-aspartate NMDA receptor antagonist It acts by non-competitive antagonism blocking the voltage-dependent ion channels

The potential of neostigmine as an adjuvant in peripheral nerve block is through its action to increase acetylcholine at muscarinic junctions of peripheral nerves 500 mcg neostigmine was used as adjuvant to local anesthetic in an axillary brachial plexus block leads to decreased pain and less use of analgesics in the first 24 hours postoperatively with no incidence of adverse effects

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None